FDA Adverse Event
Injury
Summary report: N
THAL-QUICK CHEST TUBE TRAY
MDR report key: 3894110
·
Received June 20, 2014
Report
- Report Number
- 1820334-2014-00280
- Event Type
- Injury
- Date Received
- June 20, 2014
- Date of Event
- May 16, 2014
- Report Date
- May 29, 2014
- Manufacturer
- COOK, INC.
- Product Code
- KDQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A (B)(6) MALE PT WITH SMALL CELL LUNG CARCINOMA UNDERWENT A RIGHT CHEST TUBE INSERTION INTO THE RIGHT PLEURAL SPACE ON APPROXIMATELY (B)(6) 2014. FOUR DAYS AFTER THE CHEST TUBE INSERTION, THE DISTAL ADAPTOR CONNECTING THE CHEST TUBE TO THE EVACUATION SYSTEM BECAME DISLODGED WHEN THE PT MOVED IN BED. THE CHEST TUBE WAS REPLACED OVER GUIDE WIRE DUE TO THE PRESENCE OF A PNEUMOTHORAX THAT WE COULD NOT EVACUATE WITH THE ORIGINAL TUBE. THE PT DEVELOPED A PNEUMOTHORAX. THIS CAUSED HIM INCREASED RESPIRATORY FAILURE AND HYPOXEMIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 364054 | THAL-QUICK CHEST TUBE TRAY | CATHETER, IRRIGATION | KDQ | COOK, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other |